CN106999196A - Thrombus device is taken from blood vessel removing obstructive thrombus - Google Patents

Thrombus device is taken from blood vessel removing obstructive thrombus Download PDF

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Publication number
CN106999196A
CN106999196A CN201580064164.3A CN201580064164A CN106999196A CN 106999196 A CN106999196 A CN 106999196A CN 201580064164 A CN201580064164 A CN 201580064164A CN 106999196 A CN106999196 A CN 106999196A
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Prior art keywords
thrombus
take
present apparatus
described device
bonding part
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Granted
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CN201580064164.3A
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CN106999196B (en
Inventor
D·瓦勒
B·凯西
M·吉尔瓦里
J·奥戈尔曼
K·麦卡德尔
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Neuravi Ltd
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Neuravi Ltd
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Priority to CN202010580985.5A priority Critical patent/CN111743601A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2217—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions single wire changing shape to a gripping configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/008—Quadric-shaped paraboloidal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

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  • Life Sciences & Earth Sciences (AREA)
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Abstract

It is a kind of be used to removing obstructive thrombus from blood vessel take thrombus device, it includes thrombus joint element (700), and the thrombus joint element has the shipping configuration shunk and the deployed configuration of expansion.In expanded configuration, peripheral part is laterally spaced apart from, and thrombus bonding part (700) extend between these peripheral part.Device (700) can have the waveform of two superpositions, and they are provided by amplitude curve (723) and compared with the sinusoidal pattern (721,722) of short pitch.Length of the waveform shape along device changes the contact between thrombus and device, reduces compression of the present apparatus to thrombus at some positions.The present apparatus can be with elongated when being placed under tension force, and it is elongated that this assists in keeping thrombus during displacing.

Description

Thrombus device is taken from blood vessel removing obstructive thrombus
Technical field
The present invention relates to the device for being intended to remove Severe blockage thing from blood vessel.Severe blockage thing may include thrombus, dislocation Device, device, the big embolus of displacement etc..Occurs thromboembolism when part or all of thrombus is disengaged from vascular wall.Then, this Thrombus (now referred to as embolus) is carried on the direction of blood flow.It is likely to result in if thrombus is rested in the cerebrovascular Ischemic stroke.Produced if thrombus in venous system or in the right side of heart and if resting in pulmonary artery or its branch It is likely to result in pulmonary embolism.Thrombus also can be produced partly and occluding vascular, without in the form of embolus release-this mechanism hat It is common in the forming process of shape artery occlusion.The invention is particularly suited to from acute ischemic cerebral apoplexy (AIS) In the cerebral artery of patient, from the natural of the patient with myocardial infarction (MI) or transplanting coronary vasodilator, from pulmonary embolism (PE) blood is removed in the pulmonary artery of patient and from the other peripheral arterials and vein blood vessel that wherein thrombus causes obstruction Bolt.
The content of the invention
Remove obstructive thrombus there is provided a kind of according to the present invention from blood vessel and take thrombus device, it includes having contraction Shipping configuration and expansion deployed configuration thrombus joint element, at least a portion of the wherein device has Longitudinal extending The edge of undulation extension.
In an example, the thrombus joint element has first peripheral part, second peripheral part, and at first week The thrombus bonding part extended between part and second peripheral part is enclosed, wherein, in the expanded configuration, these peripheral part It is laterally spaced apart from, the thrombus bonding part extends between these peripheral part.
In one embodiment, the edge of the undulation extension has the form of similar wave.The undulation The edge of extension can have the form of sine wave.
In an example, described device has at least two fluctuation models.The fluctuation model can be superposed on one another.One In individual example, first mode has a wavelength and amplitude, second mode have the wavelength bigger than the wavelength and amplitude of first mode and Amplitude.
In one embodiment, thrombus device is taken to include the activator appliance for being used to change wavy shape.The activator appliance can be wrapped Include at least one and push away silk and/or at least one wire drawing.
In an example, the thrombus joint element includes one or more thrombus grasping feature.
In one embodiment, thrombus bonding part is general flat in the contracted configuration.
Thrombus bonding part can be curved in the expanded configuration.
Thrombus bonding part is general flat in the expanded configuration.
In one embodiment, thrombus bonding part is substantially curved in the contracted configuration and expanded configuration.
In an example, thrombus bonding part is the form of spiral or vortex in the expanded configuration.
Thrombus bonding part can be substantially s- shapes in the expanded configuration.
In one embodiment, the thrombus joint element has two surfaces for generally facing opposite direction, and One of surface or two surfaces can be engaged with thrombus in the deployed configuration of the expansion.
In one embodiment, described device includes limiting for blood when in the deployed configuration that the device is in expansion A part for the flow channel of liquid flowing.
In an example, described device includes portions of proximal, between distal part, and portions of proximal and distal part Thrombus bonding part, wherein portions of proximal are slidably moved relative to thrombus bonding part.The portions of proximal may include can Sliding members, such as neck portion and the proximal stent stretched out from neck portion, the thrombus bonding part include nearside axostylus axostyle, and described Neck portion is slidably moved relative to nearside axostylus axostyle.At least some supports in the support of the portions of proximal can be in distad side Upwardly extend, connect for capturing thrombus at least in part when the neck portion is moved relative to nearside axostylus axostyle to nearside in thrombus Close between part and proximal stent.
In one embodiment, the fluctuation model has the amplitude from 2.0mm to 6.0mm.The fluctuation model has Pitch from 3.0mm to 8.0mm.
In one embodiment, the thrombus bonding part includes the multiple cell structures limited by support and coronal, It is at least some by the arrangement in the form of similar wave in wherein described support and/or coronal, to strengthen the insertion of thrombus.
In an example, the thrombus bonding part of described device has the horizontal stroke comprising both flat part and bent portion To section.
In one embodiment, in the expanded configuration, at least a portion phase of the thrombus bonding part of described device For longitudinal axis in substantially vortex or helical configuration.The thrombus bonding part can also include distal tubular part.In tubulose Thrombus collapsed portion can be set at partial distal end portion.
In one embodiment, the thrombus bonding part includes a pair of the siding tracks formed by cell structure element, multiple Thrombus engagement support element is connected to the cell structure element, and the cell structure element is from the plane limited by siding track Two opposite sides projection.
In another embodiment, the thrombus bonding part includes multiple sections, and adjacent section is each other with about 90 ° of arrangements.Institute State at least some sections in the section lateral cross sections with flat pattern.
In all embodiments, thrombus device is taken to may include the thrombus fragment protection part in distal side.
Present invention also offers a kind of method that obstructive thrombus is removed from blood vessel, including step：
There is provided and take thrombus device with thrombus bonding part, the fluctuation that the thrombus bonding part has Longitudinal extending rises The form of extension is lied prostrate, described device has the deployed configuration of the shipping configuration shunk and expansion；
Microtubular is promoted towards obstructive thrombus and across obstructive thrombus；
Described device is loaded into microtubular to and enters its described device the distal part of microtubular；
Deploy described device so that thrombus is embedded in；With
At least a portion of described device and the thrombus being captured are fetched into taking-up conduit.
In one embodiment, this method is included in expansion described device in thrombus.
In some instances, this method is included in thrombus and deploys institute between that part of the vascular wall of thrombus State a part for device.
In one embodiment, this method is included in described device the rear of expansion in thrombus and pulls the dress to nearside Put.
This method may include to postpone after expansion described device to pull described device to nearside, with described to nearside pulling Described device is embedded into thrombus by device and taking a step forward for thrombus.
In one embodiment, this method, which is included in, is fetched into described device described device before taking-up conduit near Layback is to bigger intravascular.
In some instances, this method includes twisting around described device described device is embedded in thrombus.
According to the present invention there is provided it is a kind of be used to removing obstructive thrombus from blood vessel take thrombus device, it includes blood Bolt joint element, the thrombus joint element has the deployed configuration of the shipping configuration shunk and expansion, the thrombus engagement member Part has first peripheral part, second peripheral part, and the thrombus extended between first peripheral part and second peripheral part Bonding part, wherein, in the expanded configuration, these peripheral part are laterally spaced apart from, and the thrombus bonding part exists Extend between these peripheral part.
In one embodiment, thrombus bonding part is general flat in contracted configuration.
In an example, thrombus bonding part is curved in expanded configuration.
In another example, thrombus bonding part is general flat in expanded configuration.
In one embodiment, thrombus bonding part is substantially curved in contraction and expanded configuration.
In an example, thrombus bonding part has the form of spiral or vortex in expanded configuration.
In another example, thrombus bonding part has substantially s- shapes in expanded configuration.
In one embodiment, the thrombus joint element has two surfaces for generally facing opposite direction, and Any surface can be engaged with thrombus in the deployed configuration of the expansion.
In an example, described device includes limiting for blood when in the deployed configuration that the device is in expansion A part for the flow channel of flowing.
In one embodiment, at least a portion of the present apparatus includes the edge that undulation extends.The undulation prolongs The edge stretched can have the form of sine wave or the form of other similar waves.
In an example, the present apparatus has at least two fluctuation models that can be applied.First mode can have wavelength And amplitude, second mode is with the wavelength and amplitude bigger than the wavelength and amplitude of first mode.
In one embodiment, the present apparatus includes the activator appliance for being used to change wavy shape.Activator appliance includes at least one Push/pull silk.
In an example, thrombus joint element includes one or more thrombus grasping feature.
The present apparatus may include distal side catching portion.
In an example, the present apparatus is formed by the flat sheet of shape-memory material, such as Nitinol.
Present invention also offers a kind of method that obstructive thrombus is removed from blood vessel, including step：
There is provided the present invention takes thrombus device；
The device is loaded into microtubular, wherein the device is in the shipping configuration shunk；
Microtubular is advanced into obstructive thrombus；
Deploy the device to catch thrombus；With
The device and the thrombus being captured are fetched into taking-up conduit together.
The present apparatus can be deployed thrombus being fixed between the present apparatus and vascular wall in thrombus.Alternately, the present apparatus Deploy in thrombus and between that part of the vascular wall of thrombus.
Brief description of the drawings
The present invention in the description of some of embodiment from below with reference to the accompanying drawings to that can be more clearly understood that, these realities Apply example only to provide by example, in figure：
Fig. 1 a are the views for taking thrombus device of the present invention；
Fig. 1 b are to include another view for taking thrombus device of distal side fragment protection part；
Fig. 2 a are the sectional views in microtubular in the thrombus area of Fig. 1 a device in the blood vessels；
Fig. 2 b are that Fig. 2 a device is in the view in the deployed configuration of expansion；
Fig. 2 c and 2d are the sectional drawings of microtubular, wherein Fig. 2 a device respectively with linear orientation and circle be oriented at by In the configuration of parcel；
Fig. 3 a and 3b are that to be deployed in the blood vessel take the isometric view and side view of thrombus device；
Fig. 4,5 and 6 is the view for taking thrombus device with a variety of cell structure shapes and cut mode；
Fig. 7 is the isometric view for taking thrombus device, and wherein flow cavity passes through the device；
Fig. 8 a and 8b are the views that the flat pattern with circular or u shape passages takes thrombus device；
Fig. 9 and 10 is the view that other with flow channel take thrombus device；
Figure 11 a to d show it is another take thrombus device, one part has flat configuration；
Figure 12 and 13 is illustrated takes thrombus device with spiral-shaped；
Figure 14 a, 14b and 15 illustrate another helical shaped devices with distal protection part；
Figure 16 illustrate it is another take thrombus device, its by along the device length twist around；
Figure 17 a are another isometric views for taking thrombus device of the present invention；
Figure 17 b are the sectional drawings of a part for Figure 17 a device；
Figure 17 c to e show the device of Figure 17 a and b in use；
Figure 18 a and 18b illustrate with flow channel it is other take thrombus device, wherein cell structure pattern and support Details is omitted；
Figure 19 a-19c illustrate that waviness takes thrombus device with what the s- shapes or u- shape cores of tubulose were combined；
Figure 20 show it is with s- shapes cross section, along device length helicoid extend take thrombus device；
Figure 21 a-21c are the views that another with flat intermediate portion takes thrombus device；
Figure 21 d show the fragment protection zone of Figure 21 a device；
Figure 21 e show a part for the center section of Figure 21 a device；
Figure 22 a-22c are isometric view, plan and the side of the thrombus bonding part of another device according to the present invention View；
Figure 23 a and 23b are to take the schematic diagram of thrombus device in use；
Figure 24 a-24c are another views for taking thrombus device of the present invention；
Figure 25 a-25c are another views for taking thrombus device of the present invention；
Figure 26 a-26d illustrate the application method for taking thrombus device of the present invention；
Figure 27 a-27d are a series of views of exemplary waveforms device；
Figure 28 a-28c are the isometric view, side view and plan for taking thrombus device；
Figure 29 a and 29b are another plans and sectional drawing for taking thrombus device of the present invention；
Figure 30 a-30f illustrate another application method for taking thrombus device of the present invention；
Figure 31 is another isometric view for taking thrombus device；
Figure 32 a and 32b are another isometric view and side view for taking thrombus device of the present invention respectively；With
Figure 33 a and 33b are another isometric view and side view for taking thrombus device of the present invention respectively.
Embodiment
Identical reference numeral in the specific embodiments of the present invention, figure is described in detail with reference now to accompanying drawing and represents identical or work( The similar element of energy.Hereinafter term " distal side " or " nearside " make when mentioning the position or orientation relative to treatment doctor With." distal side " or " distally " is away from the position at the distance of doctor one or on the direction away from doctor." nearside " or " near Side " or " close " are near doctor or the position on the direction towards doctor.
Access cerebral vessels, coronary artery and pulmonary vascular and be directed to use with many products commercially obtained and biography The operating procedure of system.The access of guide wire, guiding tube, angiography catheter and microtubular etc. with product be it is known simultaneously And be normally used in catheterization lab program.In the following description, the device and side of these products and method with the present invention Method is used in combination, but is not described in detail.
What following detailed description was merely exemplary in itself, be not meant to limitation the present invention or the present invention application and Usage.Although the description of this invention is carried out in the situation that entocranial artery is treated in many cases, the present invention Available in other body passages.
The expandable members of devices disclosed herein can be certainly when wishing by being unclamped in the shipping configuration tightened up from height The dynamic material for recovering its shape is made.Elastic material, such as Nitinol or alloy with similar performance are particularly suitable. This material can have many forms, such as silk with or piece or pipe.Particularly suitable manufacturing process be laser-cut Nitinol tube, Then the structure that thermal finalization and electrobrightening are formed, so that the framework of support and connecting element is made.This framework can be such as at this In any of disclosed wide in range form range, and can be by adding alloying element (such as platinum) or by various other Coating marks band and makes it visible under fluoroscopy.
As described in the WO2012/120490A at us, the compression to thrombus can change the performance of thrombus and lead to Cross make it harder and more " viscosity " and make the more difficult taking-up of thrombus, the entire content of the document is incorporated by reference this Text.The device of the present invention is to promote thrombus to take out by being expanded in the following manner between thrombus and vascular wall：Make some or All thrombus are layered from blood vessel, are engaged on sizable surface area with thrombus, and with the minimum side of the compression to thrombus Formula carries out aforesaid operations.Compression to thrombus is minimum, because the present apparatus significantly need not move thrombus to be expanded Open and engage with it.On the contrary, the present apparatus guides it to expand using the constraint of thrombus itself and vascular wall, in this border region Expansion.
In simplest form, the present apparatus, free thrombus bonding part has towards substantially opposite direction Two surfaces.Constrained when this thrombus bonding part is deployed in blockage by thrombus and vascular wall, it is therefore necessary to adopt Expanded with the shape of bending.The shape of this bending can be considered to have inner face (abutting against thrombus) and outside (abuts against blood Tube wall).When being transferred to target site by microtubular, the orientation of the present apparatus may not be known by user, thus can Can not be in the range of their control ability.The advantage of this design is that any surface of the present apparatus can all turn into the inner surface Or outer surface, so that the present apparatus is actually reversible.
This flat device may include compression thrombus area to be developed across the part of the channel of blood flow of thrombus.This passage is used for Two free-revving engines：1) it reduces the barometric gradient across thrombus, thus reduce the power that must pull against to withdraw from thrombus it One, and 2) it provides the circulation path that blood making oxidation, carry nutrition reaches the ischemic area in thrombus distal side.This part May include the tubulose or cylindrical shape such as shown in Fig. 7,9,10, or figure 19 illustrates part-cylindrical or " U " Shape, or the discrete portions of thrombus is moved to manufacture from distal end portion of the nearside of thrombus to thrombus without the other of thrombus passage Shape.
All devices described here can also include distal side spall-catcher part, such as shown in Fig. 1,9,12 and 14 's.It is desirable that this part is configured in the distal side of thrombus to prevent any thrombus fragment that may be discharged during taking-up It is distally moved.
Fig. 1 a show that the present invention's takes thrombus system 100 to include thrombus engagement body 101, and thrombus engages body 101 at it Proximal end is connected to axostylus axostyle 102 and is connected to fragment protection part 113 in its distal end portion.Thrombus engagement body includes axle The framework constituted to support 105 and lateral frame 107, wherein lateral frame include nearside tie point 108 and distal side coronal 106. In other embodiments, body can be engaged using the thrombus of alternative design, such as be shown in Fig. 3 to 10.In the present example, Fragment protection part 113 includes Support frame 103 and fibre substrate 104.Thrombus engages body 101 in the configuration of free-extension Shape be generally flat.The present apparatus has inner side and outer side when being unfolded in the blood vessel, wherein inner side 112 and thrombus Contact and outside 111 deviate from thrombus.The expansion orientation of the device determines which side is contacted with thrombus and which side deviates from thrombus. This both sides of the present apparatus are similar so that in the case where not influenceing device performance, either side can be launched into and thrombus Contact.The material of thrombus engagement body can be Nitinol or similar superelastic or pseudoelastic alloy, or can be stainless Steel or elastic strain are enough to allow the restorable other materials when from microtubular deploying.The material can be by flat steel product tablet Or it is cut by laser by pipe and then is further processed into flat.
Fig. 2 a show to have already passed through blood vessel by 110 sectional view of the obstructive thrombus in blood vessel 125, microtubular 109 125.Thrombectomy device 100 is illustrated in the shipping configuration in its folding in microtubular 109.In order to introduce this dress Put, first, make guide wire and microtubular 109 across thrombus or clot 110 according to standard intervention program.Then, guiding is removed Silk, leaves the present apparatus introduced according to standardization program.The flat pattern of the present apparatus allows it to be obedient to around blood vessel and in blood Expanded between bolt and vascular wall, as shown in Fig. 2 b, the present apparatus is formed ' U ' shape shape, thrombus engagement body after deployment Inner side 112 is facing to thrombus and engages, thrombus engagement body outside 111 face vascular wall.The present apparatus is positioned The contact area between thrombus and vascular wall is reduced between thrombus and vascular wall, connecing between thrombus and vascular wall is reduced Close, and reduce the power required for subsequently displacing thrombus from blood vessel.So, by withdrawing the present apparatus, thrombus can be moved out of With get back in proximally-oriented conduit or sheath (sheath), carried out if desired by means of air-breathing.Alternately, it is micro- Conduit or intermediate conductor can be moved forwardly, and so that partly sheath fills (resheath) present apparatus again, make the cell knot of device 100 Structure (cell) pattern (pattern) is closed, and thrombus is clipped between support, the grasping between the present apparatus and thrombus is improved. Again during sheath dress, the arm of " u "-shaped shape can also be bent towards thrombus, to strengthen grasping of the present apparatus on thrombus and just In taking-up.The present apparatus and thrombus can be filled by sheath again and removed completely by intermediate conductor, or by the local dress of sheath again The present apparatus and thrombus can be retracted into proximally-oriented guiding tube or sheath using intermediate conductor.This can by means of or without the help of Air-breathing is carried out.
The distal end portion of thrombus engagement body can be connected to or one to fragment protects part 113, as shown in Figure 1 b. In the configuration of free-extension, fragment protection part can be flat, tubulose, conical by its shape or irregular shape, and And can be general plane or take most to form " 3D " filtering body, such as the web frame shown in Figure 21 d. In deployed configuration in the blood vessels, this part, which is provided, catches embolus fragment, a kind of mode for preventing them from being discharged in blood flow. Fragment protection part can be formed by following constructions：The fiber of each support of the present apparatus, with line pattern, woollen yarn knitting or braiding, polymerization Thing film, or capture embolus chip, while only partially limiting the other materials of blood flow.
In the embodiment shown in Fig. 1 a, thrombus engages the cell structure that body 101 is repeated by the length along the present apparatus Pattern 107 is formed, and is flat in the configuration of free-extension.Cut mode may include various cell structure shapes Shape and unconnected coronal.
Microtubular and the detailed sectional view of the device wrapped up that Fig. 2 c and 2d show Fig. 2 a.When the present apparatus is rolled in this When in folded configuration, thrombus engagement body can be wrapped with the circular orientation 127 shown in Fig. 2 d, or the present apparatus can be wrapped Wrap up in make each support arrange with the linear orientation 126 shown in Fig. 2 c.This linear orientation folded can promote the present apparatus with linear Mode is expanded, and is easy to the present apparatus to be expanded between thrombus and vascular wall.
Fig. 3 a (with isometric view) show the embodiment of the present apparatus, and even if when deploying in the blood vessel, the present apparatus is also maintained Flat pattern.This illustrates flat device 150 and deploys in blood vessel 151 and be positioned in below obstructive thrombus 152.This dress The flat part 154 put is connected to nearside axostylus axostyle 153, in order to the introducing and taking-up of the present apparatus.Flat part 154 is by support 158 and cell structure 159 pattern constitute, they engage and are embedded into thrombus with thrombus.It can be improved using flat device The grasping of thrombus and the performance removed from blood vessel because thrombus is not compressed largely by the present apparatus, this with along thrombus Length apply radial load tube it is different.
Fig. 3 b show the side view of the device and thrombus shown in Fig. 3 a.In this view, the support of flat device 156 155 are shown as being embedded in thrombus 152.This insertion causes the part 157 of thrombus to protrude through the cell structure of the present apparatus, improves Grasping of the present apparatus on thrombus.This view specification present apparatus will realize the good grasping on thrombus and need not be too big Thrombus compression.
The level influence present apparatus that the level and thrombus of support insertion are projected into present apparatus cell structure can be applied to Grasping level on thrombus.The cut mode of the present apparatus, such as support width, length, cell structure shape and size, coronal Level in internal diameter, the design of floating coronal, all these all influences support insertion thrombus.Fig. 4,5 and 6 is shown with difference Cell structure shape and cut mode not be the same as Example.Fig. 4 is shown with the flat of many disjunct floating coronals 178 Leveling device 175.Fig. 5 shows similar flat device 200, except central coronal portion is connected together by " spine " support 208 Outside.Fig. 6 shows another structure repeatedly of flat device, and it has multiple cells that the length along flat device 225 is connected Structure 229.
Figure 7 illustrates another embodiment in, flat pattern is combined with the center section 252 of tubulose, the centre of tubulose Part 252 provides the flow cavity in thrombus during initial deployment through the present apparatus.This flow cavity 252 can be by one or logical Single tubular part is crossed to be formed.During expansion, in every side of flow cavity, the flat part of the present apparatus is still in thrombus and vascular wall Between expand.Fig. 8 a and 8b show alternative flat pattern 275, its can by heat set and be formed in the present apparatus circle or U 288.This can be realized by the way that the present apparatus is clamped in fixture 285 before the heat treatment, such as shown in figure 8b 's.Show that the cell structure pattern 280 for outside flat part 281 has and the cell knot for center U passages 279 in figure The different cell structure size and dimension of structure pattern, so that thrombus stops the dangerous cell of the blood flow in central passage upon deployment Tactic pattern, and improve the flexibility of device.
Fig. 9 illustrates device 300, and it is very similar to Fig. 7 device 250 in design, but comprises additionally in distal mesh Part 301.This distal mesh part can be attached to the distal end portion of tubular middle portion point 302 or be attached to connecting elements 303, even Connection member 303 extends through tubular element and is connected to nearside elongated axostylus axostyle 304.This distal mesh part 301 can be by one Or multiple monofilaments or fiber are formed, the fiber can be monofilament or multifilament, and this distal mesh part 301 Can be high-strength polymer material, such as ultra-high molecular weight polyethylene (UHMWPE), liquid crystal polymer (LCP), polyethylene (PE), polyethyleneterephthalate (PET), polyamide (PA), sour second diester (PEN) or aromatic polyamides, or can be Metal material.If metal material, then fiber or filament are preferably by shape memory or elastic material such as NiTi Promise is formed so that they can recover from the compressed configuration in microtubular, and form diameter and be approximately equal to the present apparatus wherein The dense net of the diameter for the blood vessel being unfolded, is distally moved to prevent tampon fragment.
Figure 10 illustrates embodiment in, the present apparatus by offer flow cavity central tubular part 321 with along this dress The arm 327 that respectively extends radially out for the length put is combined and constituted.These extend radially out arm 327 and are connected by connecting elements 325 To nearside axostylus axostyle 324, and be connected at tie point 322 fiber or silk 323 and upon deployment thrombus and vascular wall it Between expand, reduce the friction between thrombus and vascular wall.In revocation procedure, the offer of these fibers and the additional engagement of thrombus are simultaneously And help to grasp thrombus and displace thrombus from blood vessel, thrombus is taken out to the conduit of nearside or sheath.This figure also illustrates the present apparatus On nearside axostylus axostyle 324 and distal side radip-opaque end 328.
In another embodiment of the present apparatus shown in Figure 11 a-d, the flat part of device 355 is by by tube A part of heat is set to flat configuration and formed, and sees Figure 11 b.The present apparatus is set to that the part of flat configuration can be with the present apparatus by heat Tubular portion or conical section it is adjacent or between two tubular portions, or the present apparatus whole length.This forming method Flat part can be caused to include 2 layers of support and coronal 370 and 371.Cut mode of the present apparatus 354 before flattening can be configured Into after flat configuration is configured to again to have identical support pattern this two layers, its medium-height trestle and coronal are at top With bottom alignment.Alternately, support pattern is designed to not line up support, but reserves thrombus and be embedded into support 372 Between space.This allow the present apparatus be withdrawn or part sheath is attached in intermediate conductor, guiding tube or microtubular again when this A little supports clamp thrombus, see Figure 11 c.Thrombus is clamped by support to be increased grasping of the present apparatus on thrombus and improves this dress Put the ability for displacing difficult thrombus.This construction method is easy to flat part 355 and 358 distal sides of 356 and conical by its shape of tubulose Fragment protection portion split-phase is combined.
In another embodiment of the present apparatus shown in figs. 12 and 13, device 400 be formed it is spiral-shaped, wherein filling The body put submissively extends in the blood vessels, so all significantly being contacted along the whole length of the present apparatus with vascular wall.At this In example, the center line of device also forms spiral path.This device can be by the support pattern 409 needed for being cut by laser from pipe Or formed by cutting flat sheet and then wrapping up this flat part around cylinder 408 before heat setting.Therefore, originally Device has the shape similar with wrapping up wide silk ribbon around cylinder.
When being seen along vessels axis, this device will not significantly impact Endovascular.By the way that the present apparatus is positioned at Between thrombus and vascular wall, the area that thrombus is contacted with vascular wall is reduced, and this make it that the friction between thrombus and blood vessel is minimum Change and reduce expulsion power.The present apparatus also has the benefit for not compressing thrombus when thrombus is located at device intracavitary side, and this makes blood Bolt is easier to displace.Typical support sample takes bolt device (stentriever) means for engaging thrombus, thrombus is mainly positioned in this In the exterior radial surface of device, while thrombus portion projects are to the pattern of being cut, open-cell knot between support In structure.The device of the present invention is easy to that whole thrombus is positioned at into device in the case where thrombus is not by support and coronal compression Intracavitary.During being sucked with syringe or vavuum pump, thrombus is bonded on to take with support sample can prohibit on the device of bolt device Tampon is flowed to due to the engagement between thrombus and appliance stand in suction or intermediate conductor.The present embodiment of the present apparatus is easy to Suction, because thrombus does not stop the flow path in thrombus to suction lead in the intracavitary and each support of device completely.
Figure 14 a illustrate another embodiment 425 of the helical shaped devices of the present invention, and it is similar to the dress shown in Figure 12 and 13 Put 400.The present apparatus includes elongated general plane framework 429, and it can be formed by silk or by the support element being connected with each other.Framework 429 are configured as spiral type or spiral-shaped and be connected to elongated axostylus axostyle 427 in its proximal end 428, connect in its distal end portion 430 Fragment protection part 426 is connected to, fragment protection part 426 itself is terminated in distal end 431.
Figure 14 b show the side view of Figure 14 a device, clearly illustrate that fragment protects part 426, for being driven in thrombus The minimizing risk of embolic material is lost during going out and taking out.
Spiral-shaped part is used as the outer cage for engaging and removing thrombus, or as shown in Figure 15, such as There is provided make the stream that flowing recovers when deploying in thrombus for the foregoing inner part 451 being also used as like that in outer cage 453 Dynamic passage.
The additional embodiment shown in Figure 16 shows flat device 485, its by along device length twist around.This Device includes the framework of support 482.In free configuration, the center line of the present apparatus is the both sides of straight line and the present apparatus 481 by around this axis with bipitch shape twist around, similar to twist around ladder or silk ribbon.As described herein all set Meter, this part can be used for engagement thrombus to displace and removal of thromboses, or it can be a part for component and as carrying Inner part for making flow channel that flowing recovers immediately upon deployment.When as flow channel, this part is positioned in master Engage inside the outer cage of thrombus.
The device 500 shown in Figure 17 a-e has body part 501 and distal side fragment protection part 502.When along blood vessel When axis is seen, the section face of body part has ' S ' shape, as shown in Figure 17 b-e.In free configuration, The outer arm of ' S ' shape 509 is bending, and center section 510 forms diameter.The diameter of this device alterable in length, typical case Ground is in 0.5mm until in the range of 10mm.The present apparatus is designed to thrombus and portion outside the present apparatus when deploying in thrombus 515 Cell structure pattern on point is engaged, and can also be projected into the opening 511 between the arm of the present apparatus and diameter portion, Potentially fill the side of ' S ' shape.The opposite side of ' S ' shape provides shielded flow cavity 512, for when device deploys Recover blood flow.The both sides of ' S ' shape are all that equivalent and either side can be expanded as contacting with thrombus, in such as Figure 17 d and 17e Shown.The which side of the present apparatus contacts the orientation depending on expansion with thrombus.In order to displace thrombus, this dress under suction effect Put and be retracted into proximally-oriented balloon-like obturator guiding tube, standard guiding tube or sheath sheath.Alternately, it is middle Or distal side accesses conduit and can be used for applying distal side suction, and the present apparatus can be by completely or partially sheath is attached to conduit again It is interior.During the dress of sheath again, the thrombus projected into the side of ' S ' profile can be clamped and grasped by the arm of ' S ' shape, be improved Grasping of the present apparatus on thrombus.Thrombus is clamped can also be by the way that by the present apparatus, partly sheath is attached in microtubular and reality again It is existing.
The edge 505 of the arm 509 of ' S ' shape can carry profile or bending, for improving thrombus engagement simultaneously And increase thrombus is projected into the side by device.
Figure 18 a and 18b show the outer cage of the other embodiments of the present apparatus, wherein flow channel 601 and ' C ' shape 602 are shown as straight configuration (Figure 18 a) and helical configuration (Figure 18 b).These figures only show the contour line of both parts, Details without showing cell structure pattern or support, its can be it is described here and/or signal in those of appoint One.
In the alternate embodiments of that design shown in Figure 19 a-c, the flat part of device 610 has sinusoidal Or the edge 611 of similar wave, combined with the core 612 of tubulose, ' S ' shape or ' U ' shape, as in Figure 19 b and 19c Shown in sectional view.Similar wave edge 611 for flat part can improve the pliability of device, because in vascular system It is unfolded or recalled around the kink of bending in system.' S ' cross sectional shape 615 has to be carried all the time when deploying in thrombus For the benefit for fluid cavity through the present apparatus that is recovering blood flow, but regardless of orientation how.The which side of pipe device is not opened up It is split into and is contacted with thrombus, all there is shielded passage allows blood to flow through the present apparatus.' S ' shape increase thrombus and device it Between thrombus contact area, improve the ability that the present apparatus engaged and displaced thrombus with thrombus.' S ' cross sectional shape can also edge The spiral type extension of the length of device, as figure 20 illustrates.In the present apparatus by intermediate conductor partially or completely sheath again During dress, ' S ' shape also provides additional thrombus grasping, because the thrombus in the arm of ' S ' is sandwiched in support and centre Between catheter tip.
Figure 21 a-c show another embodiment 650 of device, and wherein center section 651 is formed so that, when from perpendicular to When the side of vessels axis is seen, Figure 21 b, it has sinusoidal or waveform shape 652.The present apparatus is made up of both sides, as before, Wherein one side is contacted against thrombus or with thrombus, and opposite side substantially deviates from thrombus.If device is reversed, previously faced Thrombus will be deviated from by that side of thrombus.
Device is formed as into wave-like makes length change of the contact between thrombus and device along device, reduces In position, the present apparatus is applied to the compression on thrombus.The present apparatus can also be when being placed under tension force it is elongated, such as In thrombus from during vascular system is displaced.This minimize the linear compression of thrombus and can during the displacing of thrombus Make its elongated, reduce the friction between thrombus and vascular wall, and therefore reduce the present apparatus remove thrombus needed for displace Power.
In another embodiment of the present apparatus shown in Figure 21 c, when being seen along the axis of blood vessel, device has bending Edge 655.This contact area with the increase present apparatus and vascular wall, reduction are applied to the contact on wall by the present apparatus Benefit.When being seen along vessels axis, the edge 655 of bending can be tangent with curve 657, and curve 657 mutually switches to flat part 656 Or a part for continuous curve, it is ' S ' being flattened to make cross sectional shape.This cross sectional shape has to be improved under folding configuration Wrap up the benefit of profile.This is additionally aided partially or fully sheath is attached in intermediate conductor, guiding tube, sheath or microtubular again During the bent portion of the present apparatus clamp thrombus.
Figure 21 d show that fragment protects the view of tapered portion 653, and it is formed by laser cut Nitin promise support 660 and gone back Polymer fiber can be included, to increase the density that fragment protects mesh.This tapered portion can by be cut by laser flat sheet, Then wrap up tapering shape and formed.Then, sheet material can be connected at seam 662, for example, pass through laser welding.It can replace Dai Di, seam can be kept and be not connected to, and be favorably improved so in surgical procedure if the present apparatus needs to reuse The easiness of cleaning.The coil 661 of radip-opaque or end can be added to tapered portion, for increasing fluoroscopy process In visuality.
A part for center section 651 is shown in Figure 21 e.This view shows floating or not connected coronal 665 and 667, they are formed to separate plane (out of plane) relative to the remainder of center section.Upon deployment this A little coronal contact thrombus, improve the ability that the present apparatus displaces thrombus.In addition, when the present apparatus is recalled around kink, this A little coronals keep contacting that there is provided the particular advantage for making thrombus pass through these kinks and branch and taking out with thrombus.
Figure 22 a-c show isometric view, plan and the side of the thrombus bonding part 700 of another device of the present invention View.
Device 700 includes proximal stent 706 and 707, and they can be connected to nearside slender member (not shown).These are near Side stand is distad connected to support element net, and surgical stent element net includes siding track 701 and 702, floating cell structure 705, and linking arm 703.
Each device of the present invention, such as device 700 can have the waveform pattern of two superpositions：With relative short wavelength and width The first mode of value is superimposed upon in the second mode with relative long wavelength and amplitude.The support element of the present apparatus is configured to apply Plus powerful restoring force is in first waveform pattern relatively, so that it is returned to from the relative rectilinear shipping configuration in microtubular Undulation or sinusoidal configuration when deploying in its thrombus in the blood vessel.This allow present apparatus engaged with thrombus and Thrombus is firmly gripped gently but to start to displace very much.For removal of thromboses, it is retracted into safely and is connect greatly in the present apparatus and thrombus Before receipts conduit, it may be necessary to the present apparatus and thrombus is retracted into bigger blood vessel diameter to nearside.Second waveform pattern is helped The thrombus for keeping control to be captured in this revocation procedure.With the increase of blood vessel size, the pattern of this amplitude has the present apparatus Effect ground varying dimensions make the present apparatus to keep contacting with thrombus in the bigger, blood vessel diameter closer to side to the blood vessel, Otherwise it may be expelled in the Intravascular Thrombus from the present apparatus.
Two different waveform patterns can be clear that in Figure 22 c side view, wherein whole thrombus is engaged Partial actual center line follows the larger curve 723 of amplitude, and two siding tracks 701 and 702 of the present apparatus follow section respectively The shorter sinusoidal model 721 and 722 away from (pitch).
Figure 23 a show the schematic diagram of the device 750 engaged with the thrombus 757 in vessel segment 756.Device 750 is similar to dress 700 are put, but part 751 is protected with additional debris, additional debris protection part 751 has the distal side for being added to its distal end portion End 752.Device 750 includes body part 754, and it may be connected to elongated axostylus axostyle (not shown) in proximal end 753.Body part 754 are configured as expanding into the waveform of undulation, similar sinusoidal waveform pattern upon deployment, as shown in fig. 23 a.This ripple Shape pattern includes valley 761, and valley 761 causes thrombus local contraction in the zone of dispersion adjacent with the valley, such as schemed The region 760 shown, but make the total compression in the major part of thrombus body minimum.Therefore, upon deployment, due to the work of the present apparatus With the overall characteristic of thrombus is relatively constant, but discrete region 760 is compressed and grasped by the present apparatus.This compression causes thrombus one Determine locally to be dehydrated in degree, increase its coefficient of friction, therefore increase its grasping and engagement with the present apparatus.But, because The most of of thrombus maintains not compressed by the present apparatus, so the frictional engagement of thrombus and blood vessel will not be significantly increased.
The system that Figure 23 b show Figure 23 a during when being retracted to larger diameter, in the vessel segment 758 closer to side.Herein more In the blood vessel of major diameter, body part 754 is using the second waveform pattern generally described by center line 759.This can lead to Cross and the present apparatus is configured under its free-extension state to realize using the shape shown in Figure 23 b, this can be by by NiTi Promise device heat is set to this shape and realizes, for example.Therefore, the present apparatus has when in microtubular be folded and ready for transport Certain storage energy.When deploying in thrombus, a large portion of this energy is released, so that the present apparatus is presented Figure 23 a's Shortwave long pattern.When the present apparatus be retracted into larger diameter it is intravascular when, remaining storage energy is applied in, so that present apparatus energy Long wavelength modes shown in Figure 23 b, being applied enough are presented, by increase the present apparatus effective diameter and holding and thrombus and The apposition of vascular wall, helps the present apparatus to be maintained at the grasping on the thrombus being captured.
The present embodiment and other embodiments of the present apparatus can have other waveform pattern feature, such as in the flat of Figure 22 b The curvature of siding track 701 and 702 in the figure of face, and " going out plane " projection feature, such as become apparent from showing in Figure 21 b and 21c Floating coronal 705.
The device 800 shown in Figure 24 a is another embodiment of the present invention.The present apparatus includes center section 801, at one Center section 801 is formed by flat sheet and is set to a series of flat or belt profile section waveform shapes in embodiment Shape.This section can also be by flattening cutting pipe or when being seen along vessels axis using elliptical or oval shape shape of cross section Manage and formed.In the illustrated embodiment, center section 801 is combined with fragment protection feature 802 and portions of proximal 803. Portions of proximal can be single part and be formed tubulose or conical by its shape.This part passes through one or more nearside branch Frame 804 and be connected to the present apparatus, one or more proximal stents 804 are connected to the neck portion being located on device axostylus axostyle 806 805。
Neck portion 805 can be fixed to axostylus axostyle 806 or it and can move freely and can be slided along axostylus axostyle.Figure 24 b The plan of the present apparatus is shown, wherein portions of proximal 803 is in the proximal position relative to center section 801.This is the present apparatus Typical orientation in thrombus or obturator during initial deployment.When device 800 is withdrawn to displace thrombus, due to part and blood There is friction between tube wall so the initial remains stationary of portions of proximal 803.When the present apparatus is recalled, center section 801 and thrombus phase Moved for part 803 to nearside, it is allowed to which thrombus is partly withdrawn in the presence of the support of portions of proximal.This is helped in this dress Put be retracted into larger diameter it is intravascular when grasping thrombus and prevent from losing contact with thrombus.The present apparatus, which continues to recall, to be caused All parts are shunk as single unit to nearside, because the movement of portions of proximal 803 is connected by with the nearside of center section 801 Socket part is contacted, the neck portion 805 on axostylus axostyle 806 is limited.Then, the present apparatus and thrombus can be retracted into proximal catheter, for from Vascular system is removed.
Figure 25 a show the isometric view of another embodiment of the present invention.In the present apparatus 850, similar in fig. 22 Description, body part 851 is formed with longitudinal waveform shape.The quilt also at one or more tie points 855 of body part 851 It is connected to two or more wire drawings 853 and 854.These wire drawings 853,854 extend to proximal handle (not shown), at handle User or doctor can apply pulling force to silk.By the way that these silks are placed under pulling force, thus it is possible to vary the waveform of body part 851 Profile and the pitch between valley 859 and 860 can be shortened.This can cause thrombus in the valley 856 of waveform shape Clamping increase at part.Figure 25 b show that device 850 deploys and engaged with thrombus 857 in blood vessel (not shown).Pass through system The dynamic wire drawing 853 through microtubular 858, thrombus 857 is grasped and is compressed in the valley part 856 of the present apparatus.
Figure 25 c show side view of another repetitive mode (iteration) of the present apparatus along vessels axis.In the design In, applying pulling force to wire drawing 861 and 862 by user causes the flank 863 and 864 of ' S ' shape towards the diameter portion of ' S ' 865 movements.When the present apparatus is expanded as contacting with thrombus (not shown), thrombus is clamped in the actuating of flank 863 and 864, is improved Grasping of the present apparatus on thrombus.Alternately, by the user of wire drawing 862 and 861 can improve the present apparatus it is fully expanded and The ability of thrombus is engaged in more large area.
Figure 26 a-26d show the application method of the device of the present invention.Guide wire 904 and microtubular 902 are inserted into vascular system In system 900, and it is pushed into using conventionally known technology across obstructive thrombus 901.When microtubular 902 is positioned in obstruction Property thrombus 901 distal side when, from vascular system 900 remove guide wire 904, it is micro- to allow to take thrombus device 910 to be advanced through Conduit 902.Device 910 is promoted until the distal end of the present apparatus reaches the distal end portion of microtubular 902 with the configuration of folding.It is micro- Conduit 902 is withdrawn, while the position of device 910 is maintained to deploy to take thrombus device across thrombus 901 so that device 910 distal end portion is preferably positioned at the distal side of thrombus 901.The present apparatus 910 includes being connected to elongated nearside shaft portion 911 Thrombus bonding part 912.Device 910 is expanded, so that it is engaged with waveform pattern with obstructive thrombus, this cause thrombus with Local Contraction in the adjacent zone of dispersion of the valley of the present apparatus, but make the total compression in the major part of thrombus body minimum.Root According to needs, device 910 can be allowed to be hidden in thrombus 901 a period of time.According to standard technique, by making the balloon on guiding tube Shape body 915 expands, it is possible to use the flowing in blood vessel suppresses.Constriction device 910 displaces thrombus from its position in the artery, Present apparatus meeting removal of thromboses 901 is further recalled, until it is taken back in guiding tube 903 or guiding sheath.Figure 26 d are illustrated The thrombus engaged during being fetched into guiding tube 903 with the present apparatus.Bloodstream blocking, suction and other standard techniques can be Take and use during thrombus.Device 910 can be carried out gently with flushed and before being reloaded into insertion instrument Cleaning.Device 910 can be reintroduced in microtubular with reinflated in other sections of obstructive thrombus, if desired Words.
Figure 27 a-27d show the details of the device shown in Figure 26 a-26d and illustrate the device shown in Figure 23 One embodiment.Figure 27 a show the side view of the device comprising thrombus bonding part 930 and nearside axostylus axostyle 931.Figure 27 b The plan of device is shown, and Figure 27 d show the isometric view of same device.Figure 27 c show that what is be shown specifically in Figure 27 a cuts Face figure A-A.The present apparatus can be formed by flat sheet and be set to a series of waveform shapes by heat, but keep flat cross section. In another embodiment, the present apparatus can have bending or belt profile section, or be worked as by flattening cutting pipe or using Pipe when being seen along vessels axis for elliptical or oval shape cross sectional shape is formed.As all embodiments shown here, The present apparatus can introduce fragment protection feature, for example, those such as shown in Figure 23 a and 23b.
In one embodiment, the amplitude of waveform pattern is the obstructive thrombus institute that will be taken out under free-extension state Between 0.5 and 3.0 times of the diameter of the blood vessel at place.In a preferred embodiment, under free-extension state waveform pattern width Value is between 0.5 and 2.0 times of the diameter of the blood vessel residing for the obstructive thrombus that will be taken out.In most preferred embodiment, The amplitude of waveform pattern is 0.5 He of the diameter of the blood vessel residing for the obstructive thrombus that will be taken out under free-extension state Between 1.5 times.The pitch of waveform pattern is preferably in the blood vessel residing for the obstructive thrombus that will be taken out under free-extension state 1.0 and 4.0 times of diameter between.The pitch of waveform pattern is preferably in the amplitude of waveform pattern under free-extension state Between 0.5 and 2.0 times.In the preferred embodiment that intra-arterial is used in people's brain, the amplitude of waveform pattern in 2.0mm and Between 6.0mm and the pitch of waveform pattern is between 3.0mm and 8.0mm.
Another embodiment of device is shown in Figure 28 a-28c.The isometric view of device is shown in Figure 28 a, is schemed 28b shows side view, and Figure 28 c show the plan of same device.Device 952 includes the blood for being connected to elongated axostylus axostyle 951 Bolt bonding part 950.Part 950 can be by forming as follows：Flat sheet is laser-cut into cell structure pattern and heat is set Determine into part or whole waveform pattern, good grasping of displacing is provided to be engaged with thrombus, but total thrombus compression is minimum.This Planting device may include herein any one in disclosed cell structure pattern elsewhere, and can be used for such as on Figure 26 a- Thrombus is fetched as d descriptions.Length of the waveform shape of the present apparatus along device changes the contact pressure between thrombus and device Power, forms valley 953 and groove portion 954, the present apparatus applies relatively high compression stress on thrombus at valley 953, in groove portion 954 Place's present apparatus applies very little on thrombus or does not apply compression stress.Groove portion 954 between valley 953 is used as reception space, thrombus It can be flowed freely into the space when being compressed at peak value 953.The region of higher compression allows the support of the present apparatus to be embedded in In thrombus, formation can be seen that (support) and the machinery folder of naked eyes visible (waveform pattern of the present apparatus) two kinds of levels with microscope Tightly.The present apparatus is when being placed under tension force, such as during thrombus is displaced from vascular system or elongated.This The linear compression of thrombus is minimized and thrombus can be made elongated during displacing, reduce rubbing between thrombus and vascular wall Wipe, and therefore reduce the present apparatus remove thrombus required for displace power.
Figure 29 a show the example of different flat device patterns, and it can be formed longitudinal or lateral waveform shape.Cut The pattern of cutting can be optimised, so that the valley and groove of specific cell structure feature, such as coronal or lateral frame and waveform pattern Portion aligns, to maximize thrombus insertion and grasp.For example, a line cell structure 973 can be alignd with wavelength so that coronal 974 are located in the valley of present apparatus waveform and groove portion (maximum or minimum waveforms amplitude) place.Similarly, lateral frame 975 can quilt It is positioned at the valley of waveform and groove portion, or in the centerline with middle waveform height.The outward flange of device 971 can be Bending, to minimize contacts blood pressure.
The device shown in Figure 29 a can have flat, bending or belt profile transversal when being seen along vessels axis Face, such as Figure 29 b show the sectional view (B-B) of the present embodiment.This sectional view illustrates crooked outline, before forming process or As a part for the forming process, the crooked outline can set cost apparatus by heat, for generating waveform.The present apparatus it is transversal Face shape can be the combination of flat part and bent portion, as shown in figure 29b, and wherein the present apparatus is in center section 980 It is flat, is engaged with bent portion at every side 981 and additional straight line portion 982.
Figure 30 a-30f show the application method of another device 1006 of the present invention, wherein, similar to that shown in Figure 12 Substantially spiral type or spiral configuration is presented in sample, the present apparatus in the state of free-extension.This device can be by from Guan Ji Light cut into needed for support or by cutting flat sheet and then around mandrel wrapping up this flat part before heat setting And formed.Figure 30 a-30f show the application method of the device of the present invention.Figure 30 a show the representative of artery 1001, and it has branch With the obstructive thrombus 1002 for being positioned at bifurcation.Microtubular 1003 is inserted into artery 1001 and by using conventionally known Technology promote and across obstructive thrombus 1002.Then, take thrombus device 1006 to be advanced through microtubular 1003 to reach Target site.Microtubular is retracted, while the position of holding meanss 1006 across thrombus expansion to take thrombus device, so that device 1011 fragment protection part is preferably positioned to the distal side of thrombus 1002.
Device 1006 includes being connected to the thrombus engagement of elongated nearside shaft portion and distal side fragment protection part 1011 Part 1010.The thrombus bonding part 1010 of device expands into helical configuration, it is allowed to which thrombus is partially or even wholly filled by this Put encapsulating.This allows the present apparatus to grasp and displace thrombus, while making the total compression on thrombus body minimum, is easier thrombus Remove.When initially displacing, thrombus may be positioned partially at outside or the nearside of the present apparatus, and be retracted into guiding tube or sheath During can towards device center move.Guiding tube 1005 and intermediate conductor 1004 are shown in Figure 30 b -30f. In the application method shown in Figure 30 d, intermediate conductor 1004 is moved forwardly to the surface of thrombus 1002, and by the present apparatus Apply local air-breathing before being fetched into thrombus in guiding tube 1005.The present apparatus can also and bloodstream blocking, air-breathing and taking blood Usually used other standard techniques are used together during bolt.Figure 30 e-30f illustrate, displace and be fetched into guiding tube or During in sheath 1005, how the fragment protection part of device 1011 catches the obstruction that may depart from or discharge The fragment 1012 of property thrombus 1002.
Figure 31 shows another embodiment 1030 of the present apparatus, and wherein the portions of proximal of device is by with substantially spiral type or spiral Shape shape 1031 (device 1006 for being similar to Figure 30) configures and is connected to radial direction or tubular portion 1033.Spiral part can It is connected to the other parts of nearside axostylus axostyle 1034 or the present apparatus.Distal tubular part comprising fragment protect part 1035 and by Distal side is connected to for atraumatic, radiopaque end 1032.The spiral part 1031 of diagram is schematic table Show and typically comprise laser cutting cell structure pattern.The spiral part 1031 of device, which is used to provide, to be used to displace rich in fibre The performance improved of the sticky thrombus of dimension, while tubular portion 1030 provides good during guiding tube or sheath is retracted into Good thrombus is kept.All embodiments as shown herein, before being reloaded into insertion instrument, the present apparatus can be carried out Rinse and gentle cleaning.If desired, the present apparatus can be reintroduced into microtubular, at other sections of obstructive thrombus In deploy again.
Figure 32 a show another isometric view for taking thrombus device of the present invention, are included in proximal attachment to elongated axostylus axostyle 1051 and the thrombus bonding part 1050 of optional distal end 1055 is attached in distal side.Thrombus bonding part 1050 includes A pair of the siding tracks formed by cell structure element 1052, it is small that multiple thrombus engagement support elements 1053 and 1054 are connected to these Cell structure element 1052.Support element 1053 and 1054 is from the side of the two opposite sides projection, such as Figure 32 b of the plane limited by siding track Shown in view.This design is intended to the principle operation similar with foregoing wavy device, in lateral frame 1053 and 1054 Place provides the regional area for the high insertion force being embedded into thrombus, and adjacent region has very little or none insertion or radial load. High insertion force at lateral frame forms mechanical interference between thrombus and device, the present apparatus is firmly gripped thrombus, But, because the compression to thrombus of this insertion and formation is applied on very discrete and limited region, to blood The overall performance impact of bolt is minimum.This is very important advantage, because inventor has found that the compression to thrombus can make blood Bolt becomes harder and can increase its coefficient of friction, and both may make it be more difficult to take out.
Figure 33 a show another isometric view for taking thrombus device of the present invention, and it is included in proximal attachment to slender axles Bar 1081 and the thrombus bonding part 1080 that the basket portion 1082 in optional distal side is attached in distal side.Thrombus bonding part 1080 Including multiple adjacent sections 1083 and 1084, they are arranged to approximate right angle each other.Every section 1083 or 1084 can have it is substantially flat Flat shape, but the general structure 1080 formed has three-dimensional structure, in the side view as shown in Figure 33 b it can be seen that. These alternate sections form the high compression region similar with undulating design illustrated above and the class of low constricted zone in thrombus Antitype, thrombus grasping with minimum force taking-up in terms of have similar advantage.
Although it will be apparent that the specific embodiments of the present invention have been illustrated and described, not inclined from foregoing explanation Various modifications can be carried out in the case of from the spirit and scope of the invention.For example, although embodiment reference described here Specific characteristic, but the present invention includes the embodiment that is combined with different characteristic.Present invention additionally comprises be described not comprising all Specific characteristic embodiment.
Therefore, the present invention is not restricted to previously described embodiment, can be changed in structure and details.

Claims (38)

1. it is a kind of be used to removing obstructive thrombus from blood vessel take thrombus device, it includes thrombus joint element, the thrombus Joint element has the deployed configuration of the shipping configuration shunk and expansion, and the thrombus joint element has first peripheral part, Second peripheral part, and the thrombus bonding part extended between first peripheral part and second peripheral part, wherein, described In expanded configuration, these peripheral part are laterally spaced apart from, and the thrombus bonding part extends between these peripheral part, And at least a portion of wherein described device has the edge of the undulation extension of Longitudinal extending.
2. according to claim 1 take thrombus device, wherein, the edge of the undulation extension has similar wave Form.
3. according to claim 1 or 2 take thrombus device, wherein, the edge of the undulation extension has sine wave Form.
4. according to any one of claim 1 to 3 take thrombus device, wherein, described device has at least two fluctuations Pattern.
5. according to claim 4 take thrombus device, wherein, the fluctuation model is superposed on one another.
6. thrombus device is taken according to claim 4 or 5, wherein, first mode has wavelength and amplitude, second mode tool There are the wavelength bigger than the wavelength and amplitude of first mode and amplitude.
7. thrombus device is taken according to any one of claim 2 to 6, including for changing the activator appliance of wave-like.
8. according to claim 7 take thrombus device, wherein, the activator appliance pushes away silk and/or at least including at least one One wire drawing.
9. according to any one of claim 1 to 8 take thrombus device, wherein, the thrombus joint element includes one Or multiple thrombus grasping features.
10. according to any one of claim 1 to 9 take thrombus device, wherein, thrombus is engaged in the contracted configuration Part is general flat.
11. according to claim 10 take thrombus device, wherein, thrombus bonding part is curve in the expanded configuration Shape.
12. according to claim 10 take thrombus device, wherein, thrombus bonding part is substantially in the expanded configuration Flat.
13. according to any one of claim 1 to 9 take thrombus device, wherein, in the contracted configuration and expanded configuration Thrombus bonding part is substantially curved in both.
14. thrombus device is taken according to any one of claim 11 to 13, wherein, thrombus connects in the expanded configuration Close the form that part is spiral or vortex.
15. thrombus device is taken according to any one of claim 11 to 13, wherein, thrombus connects in the expanded configuration It is substantially s- shapes to close part.
16. thrombus device is taken according to any one of claim 1 to 15, wherein, the thrombus joint element has total Two surfaces above body in the opposite direction, and one of surface or two surface energy in the deployed configuration of the expansion It is enough to be engaged with thrombus.
17. thrombus device is taken according to any one of claim 1 to 16, wherein, described device is included at the device A part for the flow channel for blood flow is limited when in the deployed configuration of expansion.
18. according to any one of claim 1 to 9 take thrombus device, wherein, described device includes portions of proximal, far Side part, the thrombus bonding part between portions of proximal and distal part, wherein portions of proximal is relative to thrombus bonding part It is slidably moved.
19. according to claim 18 take thrombus device, wherein, what the portions of proximal was stretched out including neck portion and from neck portion Proximal stent, the thrombus bonding part includes nearside axostylus axostyle, and the neck portion is slidably moved relative to nearside axostylus axostyle.
20. according to claim 19 take thrombus device, wherein, at least some supports in the support of the portions of proximal Extend in distal direction, for catching thrombus at least in part when the neck portion is moved relative to nearside axostylus axostyle to nearside Obtain between thrombus bonding part and proximal stent.
21. thrombus device is taken according to Claims 2 or 3, wherein, the fluctuation model has from 2.0mm to 6.0mm Amplitude.
22. take thrombus device according to claim 2,3 or 21, wherein, the fluctuation model have from 3.0mm to 8.0mm pitch.
23. take thrombus device according to any one of claim 2 to 22, wherein, the thrombus bonding part include by Multiple cell structures that support and coronal are limited, wherein at least some by with similar ripple in the support and/or coronal The form arrangement of wave, to strengthen the insertion of thrombus.
24. thrombus device is taken according to any one of claim 1 to 23, wherein, the thrombus bonding part of described device With the lateral cross section comprising both flat part and bent portion.
25. thrombus device is taken according to any one of claim 1 to 24, wherein, in the expanded configuration, the dress At least a portion for the thrombus bonding part put is relative to longitudinal axis in substantially vortex or helical configuration.
26. according to claim 25 take thrombus device, wherein, the thrombus bonding part also includes distal tubular portion Point.
27. according to claim 26 take thrombus device, wherein, there is thrombus fragment portion at the distal end portion of tubular portion Point.
28. according to any one of claim 1 to 9 take thrombus device, wherein, the thrombus bonding part is included by small A pair of siding tracks of cell structure element formation, multiple thrombus engagement support elements are connected to the cell structure element, described small Two opposite sides projection of the cell structure element from the plane limited by siding track.
29. according to any one of claim 1 to 9 take thrombus device, wherein, the thrombus bonding part includes multiple Section, adjacent section is each other with about 90 ° of arrangements.
30. according to claim 29 take thrombus device, wherein, at least some sections in described section have flat pattern Lateral cross section.
31. taking thrombus device according to any one of claims 1 to 30, include the thrombus fragment protection part in distal side.
32. a kind of method that obstructive thrombus is removed from blood vessel, including step：
There is provided and take thrombus device with thrombus bonding part, the undulation that the thrombus bonding part has Longitudinal extending prolongs The form stretched, described device has the deployed configuration of the shipping configuration shunk and expansion；
Microtubular is promoted towards obstructive thrombus and across obstructive thrombus；
Described device is loaded into microtubular to and enters its described device the distal part of microtubular；
Deploy described device so that thrombus is embedded in；With
At least a portion of described device and the thrombus being captured are fetched into taking-up conduit.
33. method according to claim 32, is included in expansion described device in thrombus.
34. the method according to claim 32 or 33, is included in that part of thrombus and the vascular wall around thrombus Between deploy described device a part.
35. the method according to claim 33 or 34, is included in described device the rear of expansion in thrombus and is pulled to nearside Described device.
36. method according to claim 35, is included in after expansion described device and postpones to pull described device to nearside, with Pulling described device and taking a step forward for thrombus that described device is embedded into thrombus to nearside.
37. the method according to claim 35 or 36, being included in before described device is fetched into taking-up conduit will be described Device is moved to bigger intravascular to nearside.
38. the method according to any one of claim 32 to 37, including twist around described device described device being embedded in In thrombus.
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